A Medical Device Daily

The U.S. Supreme Court is set to take up the case of Wyeth v. Levine next Monday, another case that will test the notion of FDA's pre-emption of state liability law in cases that involved a drug or device that was not used according to labeled indications.

This hearing follows a Supreme Court decision earlier this year that state law could not overrule FDA's purview of PMA medical devices in the case of Riegel v. Medtronic, in which the court voted 8-1 to overturn a lower court decision to hold Medtronic (Minneapolis) responsible for the use of its Evergreen catheter by a physician who inflated the catheter beyond the indicated range in heavily calcified arteries, which were contraindicated on the product's label (Medical Device Daily, Feb. 21, 2008).

That decision has sparked congressional opposition, with Rep. Frank Pallone (D-New Jersey), the chair of the health subcommittee for the House Energy and Commerce Committee, authoring a bill that would overturn pre-emption for PMA devices (Medical Device Daily, April 3, 2008).

The particulars of the case against Wyeth (Madison, New Jersey) run somewhat parallel to those of the Medtronic case to the extent that the product in question was used outside labeled indications.

In 2000, Diane Levine received the antihistamine Phenergan (promethazine) as a treatment for nausea associated with migraine headaches in an emergency room in Vermont. Phenergan had been on the market for longer than four decades at that time, and the drug's label indicated that it could damage arteries, possibly causing gangrene.

The medical staff member who treated Levine upon her first visit that day administered the first dose via an intramuscular injection. When Levine returned later in the day, the clinic's personnel delivered a second dose via an IV push – rather than via an IV drip – for a total of twice the recommended dosage. The drug is said to have "leaked" into an adjacent artery, setting off the damage to the arteries in her right arm that led to the amputation.

Levine is said to have settled with the clinic that treated her for $700,000, but the fact that federal law does not explicitly give FDA's regulation of drugs priority over state liability law left open the possibility of suing the company. Despite Wyeth's offer of a settlement of almost $2 million, Levine sued and won damages of almost $7 million.

The suit contends that Wyeth should have unilaterally amended the label to contraindicate the use of IV push to deliver the drug, but FDA has indicated that it does not look favorably upon unapproved changes to drug labels for fear of suppressing appropriate drug and device use.

The case is seen as offering less support for the defendant than the Medtronic case because the label for Phenergan does not explicitly contraindicate an IV push of the drug (although the label does explain the risks), but states that physicians should use "extreme care" when introducing in this fashion. Medtronic had an expressed pre-emption law on the books to bolster its case, an advantage Wyeth does not enjoy.

Regardless of the outcome, it seems almost certain that a Democratic majority in Congress will continue to push in 2009 for more leeway for lawsuits against drug and device makers, with the Medical Device Safety Act of 2008 serving as a template for future congressional activity in this area.

Docs get until May for ID theft rules

The Federal Trade Commission has announced that it will suspend until May 1 rules it had written dealing with identity theft, the so-called "red flag" rules, which were originally scheduled to take effect Nov. 1.

The rules, which were mandated by the Fair and Accurate Credit Transactions Act of 2003, were initially seen as applicable to banks and other financial services entities until recently, when doctors and healthcare facilities began to get wind of an interpretation that the rules would apply to them as well.

The red flag rules, which first saw the light of day in November 2007, essentially require any entities that extend credit or defer payment for services to develop procedures to prevent identity theft and to detect and to respond to attempts to steal such information.

The Oct. 22 FTC statement listed a range of entities that are responsible for compliance with the red flag rules, including "non-profit and government entities that defer payment for goods or services." However, in a Sept. 30 letter signed by a number of medical societies, including the American Medical Association (AMA; Chicago), FTC heard from doctors and hospitals that they became aware that "some staff attorneys in the privacy and identity theft protection section of FTC have taken the position that physicians are creditors and therefore subject to the red flag rules," assuming the physician practice bills for services.

The letter states that the interpretation of a doctor's office as a creditor does not square with the rule's description of a creditor as "any person who regularly arranges for the extension, renewal or continuation of credit," or "any assignee of an original creditor" who engages in the same business behavior. The letter also cites legal precedent, including the case of Shaumyan v. Sidetex, which involved home improvement work and which a court deemed not subject to such laws because "countless transactions in which compensation for services is not simultaneous" to the provision of that service would become, in effect, credit services.

FTC's Oct. 22 statement indicates that a number of entities informed the agency that "because they generally are not required to comply with FTC rules in other contexts, they had not followed or even been aware of the rulemaking, and therefore learned of the Rule's requirements too late to be able to come into compliance by November 1, 2008." The statement notes that the delay "will enable these entities sufficient time to establish and implement appropriate identity theft prevention programs, in compliance with the rule."